Irinotecan Hydrochloride Injection, Solution
Product Images NDC 55150-355

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 55150-355). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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First-line Irinotecan/5-fu/lv Vs 5-fu/lv Study 1 (Irinotecan Fig1)

The text seems to be a chart or a graph that shows the performance of Irinotecan/5-FU/LV and 5-FU/LV over a period of 42 months. The horizontal axis shows the months, whereas the vertical axis probably corresponds to the effectiveness or the survival rate of each treatment. The notation "0.0 +— - - - ." may represent some measurement. The chart also refers to a log-rank test, probably used to compare the two treatments. Not enough information is available to make any definitive conclusion.*

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Irinotecan-figure10 (Irinotecan Fig10)

This is a description of a pharmaceutical product named Irinotecan HCI Injection, USP, which must be diluted before intravenous use. The product comes in a 15mL single-dose vial at a concentration of 20 mg/mL. It is a cytotoxic agent, so caution is required when handling it, and any unused portion should be discarded. The product is distributed by AR AUROMEDICS and has an NDC number of 55150-354.01. The text includes some usage and storage information, as well as contact details for the manufacturer.*

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Irinotecan Fig11

The text describes a medicine called Irinotecan HCI by AuroMedics Pharma LLC. It is a sterile solution for intravenous use only and must be diluted before use. The usual dosage information is available in the package insert. It should be stored at controlled room temperature and protected from light and freezing. The drug is a cytotoxic agent and should be discarded if unused. The manufacturing is done in India for the company located in New Jersey. The code is given as TS/DRUGS/24/2015.*

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Irinotecan Fig12

This is a description of a single-dose vial of Irinotecan HCI Injection, USP, containing 500mg per 25mL on a basis of trihydrate, to be used intravenously after being diluted with Dextrose or Sodium Chloride injection. It is a cytotoxic agent and should be diluted before use. The vial should be stored upright, protected from light and freezing. The stopper is not made with natural rubber latex. This product is distributed by AuroMedics Pharma LLC and made in India.*

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First-line Irinotecan/5-fu/lv Vs 5-fu/lv Study 2 (Irinotecan Fig2)

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Figure 3. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Irinotecan Fig3)

This appears to be a graph or figure that shows probabilities on a scale from 0.0 to 0.9, and some information about Irinotecan, BSC, and a median follow-up time of 13 months with respective median results of 9.2 and 6.5 months. The note at the bottom suggests a significance level of p=0.0001 from a log-rank test.*

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Figure 4. Survival Second-line Irinotecan Vs Infusion 5-fu Study 8 (Irinotecan Fig4)

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Irinotecan-figure5 (Irinotecan Fig5)

This text is a label for a medication called "Irinotecan HCI B" manufactured in India by AuroMedics Pharma LLC. It is an injectable solution in a 2 mL single-dose vial intended for intravenous use only, and caution is advised as it is a cytotoxic agent. The label includes the NDC code, batch code, and instructions to discard any unused portion.*

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Irinotecan-figure6 (Irinotecan Fig6)

This is a description of a medication called Irinotecan HCI Injection, USP. It is a cytotoxic agent that comes in a single-dose vial containing 40mg per 2mL, and it must be diluted before intravenous use. The medication comes with a warning and unused portions must be discarded. There is information about the manufacturer, Auromedics, and the prescribing dosage is advised to be obtained from the accompanying prescription information.*

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Irinotecan-figure7 (Irinotecan Fig7)

This is a prescription-only medication used as a cytotoxic agent for intravenous use. It comes in a single-dose vial containing 100mg per 5mL of sterile, aqueous solution with 20mg/mL concentration. The medication should be stored in a controlled room temperature of 20° to 25°C (68°to 77°F), protected from light and freezing. Any unused portion should be discarded. The usual dosage should be determined by a prescribing physician. The manufacturer is AuroMedics Pharma LLC, located in E. Windsor, NJ 08520, and the medication has an NDC code of 55150-353-01.*

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Irinotecan-figure8 (Irinotecan Fig8)

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Irinotecan-figure9 (Irinotecan Fig9)

This is a description of a sterile aqueous solution with NDC code 55150-354-01. The solution should be stored between 20° to 25°C and protected from light and freezing according to USP Controlled Room i Temperature. The solution is a cytotoric agent and is for intravenous use only. The usual dosage is 300mg per 15mL (20mg/mL). The solution is a single dose vial and is manufactured in India for AuroMedics Pharma LLC. The text also includes a caution to discard any unused portion.*

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Chemical Structure (Irinotecan Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.